"Protecting the health and informed consent rights of children since 1982." June 2006
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BL Fisher Note:
In a vaccine approval frenzy putting big smiles on the faces of drug
company execs, the FDA approved Zostavax, a shingles vaccine made by Merck.
Coming on the heels of licensing a controversial HPV vaccine for genital
warts and cervical cancer that will target 11 year olds, the FDA approved a
shingles vaccine that works half the time in people over 60. Merck really
wants to market the vaccine to people 50 and older but the FDA temporarily
said "No" to that idea because studies hadn't been done.

Zostavax is actually a booster dose of Merck's varicella zoster (chicken
pox) vaccine. It is the equivalent of 14 doses of Merck's pediatric chicken
pox vaccine. The safety of injecting a "souped up" version of the pediatric
chicken pox vaccine into the often immune compromised elderly is yet another
national experiment on one of the two most vulnerable segments of our
society: the frail elderly. The elderly, along with children, often bear the
brunt of medical science's obsession with eradicating microrganisms and the
exploitation by drug companies in search of profits.
Mass use of chicken pox vaccine in American children since 1995 has
caused a shingles epidemic in older Americans. Before mass chicken pox
vaccine use, Americans who had recovered from chicken pox as children would
have their immunity "boosted" naturally and asymptomatically by coming into
contact with young children infected with chicken pox. Now, with no chicken
pox around to do the boosting for older Americans, they get shingles
instead. Chicken pox rarely causes severe complications or death in healthy
children with 50 chickenpox related deaths in children occurring annually
before mass use of chicken pox vaccine..

Some researchers (Goldman, G., International Journal of Toxicology, 2005)
estimate it will take more than 50 years of mass use of chicken pox vaccine
before the shingles epidemic will begin to subside and will affect 14.6
million Americans at a cost of $4.1 billion or about $80 million in annual
health care costs. Shingles cases result in 3 times as many deaths and 5
times as many hospitalizations in adults as chicken pox cases do in
children.

Bottom line: Drug companies double their profit potential when they
create vaccines and drugs which create diseases and disorders that require
creation and purchase of new vaccines and drugs. It gives special meaning to
the phrase "a vicious circle."

FDA Approves First Shingles Vaccine
But Some Experts Express Concerns Over Cost of Vaccine Called Zostavax

By Todd Zwillich
Reviewed By Ann Edmundson, MD

May 25, 2006 - The FDA has approved the first vaccine for adult
shinglesshingles.

The agency cleared the vaccine -- known as Zostavax -- for use in adults age
60 and older: studies showed it can prevent shingles roughly half the time.

But experts say they're worried that partial insurance coverage of the
vaccine may slow its acceptance by doctors and patients.

Shingles causes a rash with blisters that usually lasts for two to four
weeks. The pain associated with the blisters can be quite intense. Once this
initial phase is over, nerve pain called postherpetic neuralgia can set in.
This pain lasts anywhere from 30 days to months or even years. It can be so
severe in some people that it disrupts their lives.

The illness is caused by varicella, the same virus that causes
chickenpoxchickenpox. Shingles occurs when the chickenpox virus lying
dormant in nerve cells "wakes up" in older people or others with health
problems. The vaccine, Zostavax, is actually a boosted dose of the
chickenpox vaccine currently given to children.

Postherpetic neuralgia is more common in people older than 60. It occurs in
less than 10% of people younger than 60 after a bout of shingles but in more
than 40% of people older than 60.

Large Market for Vaccine

There are approximately 50 million Americans over age 60: more than 95% had
chickenpox as children, making them vulnerable to shingles.

"The market is large," says Christine Fanelle, a spokeswoman for Merck &
Co., the vaccine's manufacturer.

The company originally sought approval to sell the vaccine to adults 50 and
older. But the FDA declined after expert advisors said in December 2005 that
Zostavax hadn't been studied in patients younger than 60. The agency also
rejected a bid to approve the vaccine for preventing postherpetic neuralgia.

Up to one in ten older patients won't be candidates for the vaccine because
of weakened immune systems due to cancercancer therapy, organ transplants,
HIV/AIDSHIV/AIDS, or other causes. The vaccine contains live but weakened
varicella virus that could overwhelm the immune systems of those patients.

David Markovitz, MD, a professor of internal medicine at the University of
Michigan who reviewed Zostavax for the FDA, calls it a "highly useful"
vaccine. "It's clear the vaccine markedly reduces the incidence" of
shingles, he says.

Markovitz says that doctors may be tempted to offer "off-label" vaccinations
to adults age 50 to 59 in hopes of providing earlier protection against
shingles. "Off-label" refers to drugs that are used in ways that have not
been not approved by the FDA. But he stressed that the vaccine remains
unstudied in such patients and that researchers still don't know how long
immunity lasts after vaccination.

"I don't think I would rush out and get it myself," Markovitz, who is 52,
tells WebMD.

Insurance Coverage Worries

Other experts worried about the vaccine's cost. Zostavax is slated for
coverage under MedicareMedicare's Part D prescription program. But under the
program, individual private insurance plans set prices, meaning that
coverage for the vaccine could vary substantially among hundreds of plans
nationwide.

Medicare and private insurers often base coverage decisions on counsel from
the Advisory Committee on Immunization Practices (ACIP) at the CDC.

The committee is expected to make recommendations next fall advising the
government, insurers, and doctors, on how many older Americans should
receive the shinglesshingles vaccine.

Insurance coverage inside and outside of Medicare could have a large impact
on how many adults seek the vaccine. "We certainly think that's very
important," Fanelle says.

William Schaffner, MD, chair of the department of preventative medicine at
Vanderbilt University and an ACIP member, says that partial insurance
coverage could impede lower-income people from purchasing the vaccine and
limit its spread among patients who could benefit.

"Many of us are distressed about that possibility," notes Schaffner, who
says he received financial payment from Merck to discuss Zostavax with
reporters.

Follow-Up Study

The company followed patients in its study for four years. Officials told
the FDA that they plan to follow patients for 10 years to determine how long
patients retain immunity before requiring boosters. The company is also
planning to study the vaccine in immunocompromised patients, officials said
in December.

Markovitz says the company's original study focused on whites and that the
company should also expand testing in minorities, who can have varying
immune responses.

"Realistically, we can say this works in white people, and it's just too bad
this continues to happen in every darn study," he said.

May 27, 2006
Vaccine to Cut Risk of Shingles in Older People Is Approved
By GARDINER HARRIS

WASHINGTON, May 26 - Federal drug regulators have approved the first vaccine
intended to reduce the risk of shingles in people 60 and older.

The vaccine, called Zostavax, is a souped-up version of the chickenpox
vaccine. Both chickenpox and shingles are caused by the herpes zoster virus,
which is present in almost everyone. The approval was announced on Friday.

Zostavax, made by Merck, works by mimicking a shingles attack, but without
the pain or blisters that shingles causes. The vaccine strengthens the
body's immune response against the virus, reducing the chances of an
outbreak, as well as the severity of the disease if it does occur.

The science behind the vaccine is relatively simple. Zostavax is roughly
equivalent to 14 doses of the pediatric chickenpox vaccine.

Nonetheless, Zostavax represents a significant breakthrough, several
scientists said. It is the first therapeutic vaccine, meaning it prevents or
eases the severity of the problems from an infection that has already
occurred.

Scientists have been hoping to create such vaccines against cancer and AIDS,
but without much success.

"It's a breakthrough in that it's the first vaccine that is actually
designed to keep an infection in check," said Dr. Walter Orenstein,
associate director of the Emory Vaccine Center at Emory University, who has
consulted for Merck.

Zostavax is also the first vaccine in 30 years that is intended exclusively
for older people, and it comes in the midst of a minor surge in nonpediatric
vaccines.

Last year, the Food and Drug Administration approved Menactra, a vaccine to
prevent meningococcal meningitis. Menactra is generally given to teenagers.
And Merck is expected to gain approval next month for a cervical cancer
vaccine that is likely to become popular among teenagers and young adults.

The herpes zoster virus normally lives neutered and imprisoned in nerve
cells buried near the spine. During a shingles outbreak, the body's prison
guards - crucial parts of the immune system called lymphocytes - become
weakened and allow the virus to escape. The result is a painful itch that
usually starts at the spine and travels across the midsection on one side of
the body. This pain is often followed by a belt of blisters.

Outbreaks can recur, and the virus can significantly damage nerve cells and
lead to pain that can endure for months or years. Zostavax primes again the
body's defenses against the virus.

There are an estimated one million new cases of shingles in the United
States each year, and the risk of contracting the disease ranges from 10
percent to 30 percent over a lifetime. For those over 85, the risk hovers
around 50 percent. The incidence of the disease has gradually increased for
decades, perhaps because of longer lives.

About half of all cases occur in those over 60, but younger people with
immune problems, AIDS or cancer also have a higher risk.

To prove Zostavax effective, Merck sponsored a trial in 38,546 people over
60 who had never had shingles. Half got the vaccine, and half received a
placebo. After three years, those who did not receive Zostavax suffered
twice as many shingles cases as those who did.

Perhaps just as important, those who received the vaccine and then developed
shingles generally experienced less pain than those who received placebos.

"The best way to treat chronic pain is to prevent it," said Dr. Anne Louise
Oaklander, an associate professor of neurology at Harvard Medical School,
who described the vaccine as a landmark. "Shingles is the most common
neurological disease in the country."

Merck will charge $152.50 for the vaccine, which is administered with a
single injection. Doctors will probably charge more.

Merck expects to begin shipping the vaccine "soon," the company said in a
news release. But its adoption may be slow, because doctors must store the
vaccine in freezers, and many geriatricians do not have freezers in their
offices.

Catherine Arnold, a senior research analyst at Credit Suisse, an investment
bank, estimated that Zostavax would generate $1 billion in sales for Merck
by 2010.

"But I could be biased," said Ms. Arnold, who suffered a painful case of
shingles that began in September 2004 and has only recently subsided. The
pain was so intense that she underwent a spinal injection of steroids and
ended up taking a collection of other drugs orally.

"It was my constant foe for almost two years," she said. "I can imagine
being over 60, and being in less-good health, and being really miserable."

Since Zostavax uses the same medicine as the pediatric chickenpox vaccine,
it is expected to be extremely safe, Dr. Oaklander said. In tests, the
vaccine caused some tenderness at the injection site and a slight increase
in headaches. It is not expected to be of use in treating a shingles attack.

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